FDA approves first generic version of EpiPen in time for device shortage

The first generic version the EpiPen has been approved by the FDA.

anaphylaxis

Teva Pharmaceuticals’ generic version of the epinephrine auto-injector has been approved by the FDA in a push from the organisation to approve more generic products.

The generic version will act as a replacement for brand name versions by device maker Mylan, which came into controversy in 2016 when it raised the price of its EpiPens from $56 per pen to $317.

The approval also follows a shortage of EpiPens within the US market caused by delays from manufacturers. Teva’s generic now means the market has a substitutable epinephrine auto-injector across two different strengths.

EpiPen autoinjectors are used to treat people who can suffer from severe allergic reactions and are potentially life-saving devices.

There are other version of epinephrine auto-injectors but Teva’s is the first device to be considered a generic to the branded EpiPen.

Speaking about the approval, Teva said in a statement: “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market."

FDA Commissioner Scott Gottlieb said: “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.”